The use of marking pens on surgical patients prior to surgery is common. A surgeon will often use pens to mark lines or designate areas on a patient's body so as to know the proper place for an incision or other surgical procedure that will be performed during the operation. In such cases, it is extremely important that the incision or procedure site be at the correct location. However, with the use of these marking pens, certain specific procedures can result in drapes covering the pen marking and therefore the site marking is no longer visible to the surgeon's eye.
Intraoperative medical imaging (i.e. imaging that occurs within the operating room) is frequently used by a physician to help plan and perform their procedure accurately and efficiently. Intraoperative imaging can assist with identifying the procedure site and guiding the physician during the procedure. Various imaging modalities can be utilized, including, but not limited to: fluoroscopy (also referred to as a “c-arm”), plain X-ray, CT and MRI. The term “medical imaging” is herein used in its broadest sense and “intraoperative imaging” refers to medical imaging that occurs within the operating/procedure room.
Wrong site surgery (“WSS”) can be a devastating event with profound medical, legal, and social ramifications. The term “wrong site” can include the wrong site, side, limb, level, organ, or patient. The term “surgery” can also include medical procedures that do no utilize an incision, such as ureteroscopy. WSS is also defined as a sentinel event (i.e., an unexpected occurrence involving death or serious physical or psychological injures, or the risk thereof) by the Joint Commission (“JC”, also formerly called the Joint Commission on Accreditation of Healthcare Organizations), which found WSSs to be the third highest ranking event.
Although termed a “never event” in the medical community, WSS continues to occur. The JC and the World Health Organization (“WHO”) have each launched a surgical checklist/protocol to help reduce the risk of performing a WSS. The JC's universal protocol includes 3 parts: (a) preoperative verification; (b) marking of the operative site; and (c) a “time-out” immediately before starting the procedure.
The second element of the universal protocol is marking the operative site. Although the JC allows any member of the team to mark the site, ideally it should be done by the physician that performs the procedure. This is required whenever the procedure involves a bilateral distinction or when multiple structures or different levels are involved. It is not required for sternotomy, cesarean section, or laparotomy/laparoscopy, unless right or left organs are involved. Some exclusions also include (a) patient refusal to be marked; (b) cases in which it is technically or anatomically impossible or impractical to mark the site; (c) minimal access procedures to treat a lateralized internal organ, whether percutaneous or through a natural orifice (the intended side is marked at or near the insertion site); (d) interventional procedures for which the catheter or instrument insertion site is not predetermined; and (e) teeth. It should also be noted that not all medical facilities follow the JC or WHO checklist. A facility may also choose to mark the incorrect site that the procedure is not to occur on.
Some surgical procedures do not require an incision, such as an ureteropscopy. An urologist will insert an ureteroscope into the urethra and pass it through the bladder and the ureter, to get to where the kidney stone, or other target, is located. The kidney stone, or target, is then removed or treated.
Although each medical facility may have their own protocols in place, in general, each facility will perform their ureteroscopy procedure in similar steps. The patient is first identified in the holding area according to the preoperative verification step of the universal protocol. The laterality is confirmed by verification with the patient and confirmation of the preoperative radiologic images. The physician then marks the correct side with an indelible marker in the groin or abdomen area. This marking can vary depending on a facility's protocol, but usually consists of either an “X”, checkmark, the word “Yes”, or the operating physician's initials. The patient is later brought into the operating/procedure room where anesthetization, draping and other pre-procedure prepping events occurs. A “time-out” is performed before the procedure starts to confirm with the medical team the correct patient identity, correct site and correct procedure to be done. This confirmation is usually verbal or via filling out a checklist. The invasive portion of the ureteroscopy procedure can then begin.
Certainty is needed for an ureteroscopy not only to acknowledge the correct intended side, but also to ensure the procedure is actually performed on the correct intended side. The problem with the universal protocol and its possible modifications a facility may incorporate, with respect to endourologic procedures, is that the site marking is no longer visible once the patient is draped; the site marking does not appear on the medical image; and a physician can become confused with the patient and/or medical image's orientation.
The WSS prevention mark is made before the patient enters the operating room because it is suggested to include the patient in this process. Although this indelible mark remains on the patient, usually on the groin/abdomen area, the mark is eventually covered by surgical drapes before the procedure begins. The patient is completely draped except for a small opening over the genital area because the procedure is done through the urethra. Draping defeats the purpose of marking the patient because the physician can no longer see the mark on the body. The mark is also not visible on intraoperative medical imaging.
The indelible marker used by the physician can be a surgical marker, such as something gentian violet based (ex. a Viscot Medical LLC Surgical Marker), or something as common as a Sharpie. This marker is highly visible to the eye, however, does not appear on a medical image scan because the ink is not radiopaque. If the mark is neither visible on the patient's body or the intraoperative medical image scan, then marking the patient's skin is moot.
During the pre-operative stage of the universal protocol checklist, the correct procedure and site is confirmed. This can be noted on the checklist as an “ureteroscopy on the left ureter”. An ureteroscopy is commonly performed with the surgeon located between the patient's spread legs, with the patient positioned supine and the physician facing the patient. Confusion can occur with orientation because the patient's left ureter is on the physician's right side. If the medical image is set to mimic the orientation that the physician is experiencing while between the patient's legs, the left side of the patient will be on the right side of the screen. However, the physician or technician may also inadvertently flip the displayed image. This would result in the patient's left kidney on the left side of the image, but the procedure is being performed on the physician's right hand side.
Due to the relatively small image size, there may also be a lack of anatomic detail on fluoroscopy for orientation and to distinguish between the patient's left and right side. Furthermore, as vision is often limited to what is on the image's video screen, others in the operating room do not have the ability to determine which side of the patient the procedure is being performed on.
It is more natural for a person to autonomously think a left side procedure is performed in the direction of their left side, and viewing the medical image to think that the left side of the image correlates to the left side of their patient. Although a physician is trained to overcome orientation confusion, mistakes still occur as 20% of wrong site surgery is urologic.
A technique some facilities utilize to mark the correct side of the body is to use a colored band around the patient's wrist or ankle and have it sticking outside of the drapes. The surgeon can reference the colored band as a redundancy to confirm the correct procedure side. The problem with this is that patient is no longer fully draped and part of their body that should be covered is now exposed. In addition, the colored band, whether on the ankle or the wrist is beyond the procedure area and requires the surgeon to remember to look for a marking that is not on the procedure area they are focused on. A band around the ankle will be behind the surgeon because they are performing the procedure between the patient's spread legs. This requires the surgeon to perform an added step of turning around to view the colored band. It is ideal to mark the correct side by having the site marking within the procedure area.
Prior art methods have utilized radiopaque adhesive markers to label the patient. “Prevention of Wrong Site Surgery During Upper Tract Endoscopy” by Warren et al. utilized self-adhesive disposable radiopaque stickers by Beekley Medical. These radiopaque stickers are visible during intraoperative imaging and labeled with the letter “R” or “L”, to mean “right” and “left” respectively. The “R” is adhered to the right side of the patient and the “L” is adhered to the patient's left side. Although this labels the patient's right and left side and helps with orienting the patient, this is an ambiguous technique because it does not label which is the correct site to operate on. These labels also lack the ability to standardize a consistent marking system implemented by the physician or medical facility. The surgeon's usual technique may be to write the word “Yes” on the correct site, however, some procedures would have the “R” or “L” markings. This can lead to confusion because some procedures will have different markings.
It is unclear if a unilateral procedure suggests having both the “R” and “L” adhered, or only a single marker. The images show a single “L” for a left ureteroscopy procedure and both an “R” and “L” for a bilateral ureteral procedure. It can be confusing in the sense that it is unclear which the intended target side(s) is/are. A single “L” marker on the patient's left side could be interpreted that it is the left side that needs treatment, due to there being a lack of an “R” marker. However, it can be interpreted that the single “L” marker is just a reference point to provide clarity on orientation. It can be confusing in the sense that a physician can think of this as a reference direction to inform them of the patient's left side so they can then identify the remaining directions based on the location of the “L” marker. This is analogous to a map showing only the direction of North and relying on the user to identify remaining directions; while such marking may be sufficient on a map because everyone is familiar with compass rose directions it is ambiguous when it comes to patient marking and the physician does not have 100% clarity on the correct procedure side(s) with this method.
It is a general norm when a plain X-ray is taken in radiology (outside the operating room), that an “R” or “L” radiopaque marker is placed. For example, a single hand scan may have an “R” marker on the image to label it as being the right hand. This does not mean a procedure needs to be done on the right hand, it only labels that it is the right hand in the scan image. A chest X-ray may contain a single “R” or “L” marker on the correct side to identify the correct orientation of the patient. For example, having an “L” marker on a chest X-ray does not necessarily mean that there is an issue with the patient's left side.
It is second nature for a surgeon to think an “R” or “L” marker as an orientation reference of the X-ray image. If only a single body part is identified, such as a hand, the surgeon generally interprets the “R” or “L” marker on the image as identify which side the body part belongs to. The authors are now expecting the surgeon to have multiple meanings for the “R” and “L” symbols, one being that it could identify the correct site(s)/side(s) and a second as simply labeling which body part is being imaged.
Having multiple meanings creates risk of error. For example, the initial preoperative X-ray image may scan both the right and left kidney for diagnostic purposes. An “L” marker may be placed on this preoperative scan image to provide a reference of the patient's orientation. If the treatment site is the right kidney and a single “R” sticker is placed on the right side before treatment, the physician is reliant on two different interpretations. The surgeon may recall from memory seeing an “L” on the patient's scans and inadvertently perform the procedure on the left side. This could occur if the c-arm does not image the right side, because the viewing area of a c-arm could be much smaller than a plain X-ray. So if the surgeon does not see the “R” sticker, a WSS could occur. In addition, if the diagnostic image is available in the operating room, the surgeon would see the “L” sticker. If the “R” sticker was placed on the right side of the patient and signaled that was the intended procedure side, the surgeon could be confused because the see an “L” sticker on one image and an “R” sticker another image. This ambiguity creates risk of a WSS.
In the scenario that both the patient's left and right side is labeled with these radiopaque stickers, it brings up similar uncertainty as described above. The physician can interpret this as simply labeling which sides are the patient's left/right and each label does not necessarily validate that both sides require treatment. It can also be interpreted that both sides need treatment because two marks are present.
Although it is recommended that the physician directly apply the sticker, therefore assuming the above described confusion would not occur because the applier is aware of their intentions, because no definitive system is described, it is relied on each individual physician to implement their own method and to remember it. Without a consistent method, there is no certainty that the physician will apply a sticker and recall with 100% certainty if the label means to perform the procedure over the respective marker, or if that marker only labels the patient's orientation.
“Point of Technique: Reducing Wrong-side Errors for Endourology Procedures” by Alleemudder et al. describes a similar technique by Warren et al. Due to the “R” and “L” stickers not being readily available in departments compared to electrocardiography (ECG) tabs, the authors utilized SKINTACT ECG electrode tabs as a radiopaque marker. The ECG tab was placed over the correct procedure side. This removes most of the uncertainty described above, however, the radiopaque item that forms the ECG tab is a small pellet. Using a small pellet, although visible, is not the most user friendly. It can take time for the physician's eye to scan the image until the small pellet is located. It can be especially difficult if the pellet overlaps with a dense bone. The editor also comments that a radiopaque marker is not limited to “R” or “L” stickers or ECG tab. The site can be marked with any “visible” radiopaque marker, such as a paper clip. However, using homemade or non-standardized items creates the possibility of having a system that is not consistent and ambiguous among the medical facility and its staff members. Having individuals perform various different techniques or using different radiopaque markers can create confusion and ultimately exposes the patient to risk of WSS.
The current methods described above demonstrate that there is a distinct need for apparatus and methods that allow a medical professional to visibly mark, on the patient and medical image, the correct site(s)/side(s) of a endourologic procedure in a clear, consistent, unambiguous manner that cannot only be used by a single individual, or throughout a single facility, but also universally in multiple facilities. The apparatus would benefit from a cheap, universal marker specifically designed for an endourologic procedure and further reduces the risk of a WSS.
Other prior art solutions include apparatus and methods of improving surgical site marks. None of the prior art addresses the problems and solutions of overcoming indelible marks that are covered by drapes using unambiguous techniques that can be consistent with a physician or medical facility's protocols in place.
It is an object of the present invention to overcome one or more of the above described drawbacks and/or disadvantages of the prior art apparatus and methods.